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Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities - Webinar

  • ID: 4899714
  • Webinar
  • November 2019
  • Region: Global
  • 90 Minutes
  • Compliance Online
Why Should You Attend:

The session will include requirements for complaint files and key requirements of:

Complaint procedures
Investigations
What to document when it is determined that an investigation is not needed
What actions are required if a complaint represents a reportable event
Record retention

In addition, the webinar will incorporate the complaint handling life-cycle process and an example of activities involved in this life cycle. Furthermore, this webinar will discuss complaint handling implementation challenges, in addition to pitfall challenges. At the end of this webinar, there will be a conclusion section, where points to take into account with the integration of CAPA/change control/adverse event reporting/recalls/complaint files in the complaint handling life-cycle, will be detailed.

Areas Covered in the Webinar:

Complaint definition
Medical device and drug complaint handling requirements (US)
Complaint sources
Interrelationship of complaint handling, CAPA, change control, adverse event reporting and recalls
Reportable events: when does a complaint become a reportable adverse event; what in itself is a reportable event; how does user error relate to adverse event reporting; voluntary and mandatory reports, and reporting timelines
What may trigger a recall during the complaint investigation
Recall classifications
Complaint handling life-cycle process (including an example that embraces activities related to bullet four, above)
Challenges
Conclusion
References
Note: Product cover images may vary from those shown
Ms. Lopez has held a wide variety of leadership roles in the Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as the Consulting Services industry. She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly, Pall LifeSciences, among others. She possesses over 25 years of experience focused on development, implementation, driving improvements and monitoring of Quality Assurance, Quality Control, Regulatory Compliance, Regulatory Affairs, Quality Systems and Supplier Quality activities. Ms. Lopez has in-depth knowledge, coaches on interpretation and application of US regulations, EU directives, specific country regulations (Japan, Canada, and others), national/international standards and guidance documents. She has also held positions within the CAPA, Material, Safety and Management Review Boards as well as represented Quality in Design Control phases.
Note: Product cover images may vary from those shown